The FDA has approved a new indication for Boehringer Ingelheim and Eli Lilly’s Jardiance saying it can reduce the risk of cardiovascular death in patients with type 2 diabetes and underlying cardiovascular disease.
It is the first time that any diabetes treatment has been approved with a cardiovascular claim and – according to Evercore analyst John Scotti – this could boost sales of SGLT-2 inhibitor Jardiance (empagliflozin) by as much as $1.7bn by 2025.
The approval could lead to updated treatment guidelines that will encourage greater use of Jardiance, particularly among primary care physicians.
Last year, the results of the EMPA-REG OUTCOME trial of Jardiance hit the headlines after they showed for the first time conclusively that using drugs to control blood glucose in diabetics can lower risk, cutting the rate of cardiovascular death by 38%, and reducing all-cause mortality by 32%.
Despite the excitement generated by the results, and particularly by how quickly the benefits seemed to appear after starting treatment, the FDA was by no means assured of approving the claim. In fact, its advisory committee voted only by the narrowest of margins (12 to 11) in favour of approval earlier this year.
The green light will end an anxious period for the two drugmakers. Full approval was not a given as the US regulator could have opted to simply add the data to the label – which would have been harder to promote – or even have waited for data from a cardiovascular outcomes trial involving rival SGLT2 inhibitor Invokana (canagliflozin) from Johnson & Johnson, due to report next year.
Another SGLT1 inhibitor – Bristol-Myers Squibb/AstraZeneca’s Forxiga/Farxiga (dapagliflozin) – is also in a cardiovascular outcomes trial that is not due to generate results until 2019.
Enrique Conterno, who heads up diabetes at Lilly, said that “despite significant medical advances, approximately two out of three people with type 2 diabetes still die from cardiovascular disease”.
He added that the company would be stepping up efforts to educate the public about the link between diabetes and cardiovascular disease.
Lilly reported sales of $126m in the first nine months of the year, well shy of the $1.03bn booked by J&J for its Invokana franchise (including metformin combination product Invokamet) in the same period. Lilly said recently its drug has been wresting market share from its rivals among new scrips since the publication of the EMPA-REG data.